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ID

32727

Beschrijving

Study ID: 109059 Clinical Study ID: OTB109059 Study Title: TXA107979:A Phase II Study to Evaluate: Delay in Intravaginal Ejaculatory Latency Time (IELT), Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Two Oral Doses of GSK557296 in a Randomized, Double Blind, Placebo-Controlled, Parallel Group Study in Men with Premature Ejaculation Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01021553 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: epelsiban Trade Name: Study Indication: Premature Ejaculation

Trefwoorden

  1. 13-11-18 13-11-18 -
Houder van rechten

GlaxoSmithKline

Geüploaded op

13 november 2018

DOI

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Licentie

Creative Commons BY-NC 3.0

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    Delay in IELT, Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of GSK557296 in Men with Premature Ejaculation, 109059

    Vital Signs

    1. StudyEvent: ODM
      1. Vital Signs
    Vital Signs - Supine
    Beschrijving

    Vital Signs - Supine

    Alias
    UMLS CUI-1
    C0518766
    UMLS CUI-2
    C0038846
    Actual date/time
    Beschrijving

    Vital Signs, Date in time, Time

    Datatype

    datetime

    Alias
    UMLS CUI [1,1]
    C0518766
    UMLS CUI [1,2]
    C0011008
    UMLS CUI [1,3]
    C0040223
    Blood Pressure - Not done
    Beschrijving

    Blood Pressure, Supine Position, Not done

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C0005823
    UMLS CUI [1,2]
    C0038846
    UMLS CUI [1,3]
    C1272696
    Blood pressure systolic
    Beschrijving

    Systolic pressure, Supine Position

    Datatype

    integer

    Maateenheden
    • mmHg
    Alias
    UMLS CUI [1,1]
    C0871470
    UMLS CUI [1,2]
    C0038846
    mmHg
    Blood pressure diastolic
    Beschrijving

    Diastolic Blood Pressure, Supine position

    Datatype

    integer

    Maateenheden
    • mmHg
    Alias
    UMLS CUI [1,1]
    C0428883
    UMLS CUI [1,2]
    C0038846
    mmHg
    Heart rate - Not done
    Beschrijving

    Heart rate, Supine position, Not done

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C0018810
    UMLS CUI [1,2]
    C0038846
    UMLS CUI [1,3]
    C1272696
    Heart rate
    Beschrijving

    Heart rate, Supine position

    Datatype

    integer

    Maateenheden
    • bpm
    Alias
    UMLS CUI [1,1]
    C0018810
    UMLS CUI [1,2]
    C0038846
    bpm
    Vital Signs - Standing
    Beschrijving

    Vital Signs - Standing

    Alias
    UMLS CUI-1
    C0518766
    UMLS CUI-2
    C0231472
    Actual time
    Beschrijving

    Vital Signs, Date in time, Time

    Datatype

    datetime

    Alias
    UMLS CUI [1,1]
    C0518766
    UMLS CUI [1,2]
    C0011008
    UMLS CUI [1,3]
    C0040223
    Blood pressure - Not done
    Beschrijving

    Systolic pressure, Standing position, Not done

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C0871470
    UMLS CUI [1,2]
    C0231472
    UMLS CUI [1,3]
    C1272696
    Blood pressure systolic
    Beschrijving

    Systolic pressure, Standing position

    Datatype

    integer

    Maateenheden
    • mmHg
    Alias
    UMLS CUI [1,1]
    C0871470
    UMLS CUI [1,2]
    C0231472
    mmHg
    Blood pressure diastolic
    Beschrijving

    Diastolic Blood Pressure, Standing position

    Datatype

    integer

    Maateenheden
    • mmHg
    Alias
    UMLS CUI [1,1]
    C0428883
    UMLS CUI [1,2]
    C0231472
    mmHg
    Heart rate - Not done
    Beschrijving

    Heart rate, Standing position, Not done

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C0018810
    UMLS CUI [1,2]
    C0231472
    UMLS CUI [1,3]
    C1272696
    Heart rate
    Beschrijving

    Heart rate, Standing position

    Datatype

    integer

    Maateenheden
    • bpm
    Alias
    UMLS CUI [1,1]
    C0018810
    UMLS CUI [1,2]
    C0231472
    bpm

    Similar models

    Vital Signs

    1. StudyEvent: ODM
      1. Vital Signs
    Name
    Type
    Description | Question | Decode (Coded Value)
    Datatype
    Alias
    Item Group
    Vital Signs - Supine
    C0518766 (UMLS CUI-1)
    C0038846 (UMLS CUI-2)
    Vital Signs, Date in time, Time
    Item
    Actual date/time
    datetime
    C0518766 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    C0040223 (UMLS CUI [1,3])
    Blood Pressure, Supine Position, Not done
    Item
    Blood Pressure - Not done
    boolean
    C0005823 (UMLS CUI [1,1])
    C0038846 (UMLS CUI [1,2])
    C1272696 (UMLS CUI [1,3])
    Systolic pressure, Supine Position
    Item
    Blood pressure systolic
    integer
    C0871470 (UMLS CUI [1,1])
    C0038846 (UMLS CUI [1,2])
    Diastolic Blood Pressure, Supine position
    Item
    Blood pressure diastolic
    integer
    C0428883 (UMLS CUI [1,1])
    C0038846 (UMLS CUI [1,2])
    Heart rate, Supine position, Not done
    Item
    Heart rate - Not done
    boolean
    C0018810 (UMLS CUI [1,1])
    C0038846 (UMLS CUI [1,2])
    C1272696 (UMLS CUI [1,3])
    Heart rate, Supine position
    Item
    Heart rate
    integer
    C0018810 (UMLS CUI [1,1])
    C0038846 (UMLS CUI [1,2])
    Item Group
    Vital Signs - Standing
    C0518766 (UMLS CUI-1)
    C0231472 (UMLS CUI-2)
    Vital Signs, Date in time, Time
    Item
    Actual time
    datetime
    C0518766 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    C0040223 (UMLS CUI [1,3])
    Systolic pressure, Standing position, Not done
    Item
    Blood pressure - Not done
    boolean
    C0871470 (UMLS CUI [1,1])
    C0231472 (UMLS CUI [1,2])
    C1272696 (UMLS CUI [1,3])
    Systolic pressure, Standing position
    Item
    Blood pressure systolic
    integer
    C0871470 (UMLS CUI [1,1])
    C0231472 (UMLS CUI [1,2])
    Diastolic Blood Pressure, Standing position
    Item
    Blood pressure diastolic
    integer
    C0428883 (UMLS CUI [1,1])
    C0231472 (UMLS CUI [1,2])
    Heart rate, Standing position, Not done
    Item
    Heart rate - Not done
    boolean
    C0018810 (UMLS CUI [1,1])
    C0231472 (UMLS CUI [1,2])
    C1272696 (UMLS CUI [1,3])
    Heart rate, Standing position
    Item
    Heart rate
    integer
    C0018810 (UMLS CUI [1,1])
    C0231472 (UMLS CUI [1,2])

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